Developing first in class drugs for cardiovascular and metabolic diseases
Serodus ASA is a drug development company listed on the Norwegian stock exchange. We focus on developing new treatments with unmet clinical needs in the areas of cardiovascular diseases and diabetes. Our business model is to in-license drug candidates at an early stage. After having demonstrated clinical effects in humans during clinical phase II, we partner with international pharmaceutical companies. Serodus manages the business processes through our extensive network of contract organizations. We are a virtual organization and have no laboratories of our own. The Serodus Management Team combines the weight of Big Pharma experience with the agility of BioPharm decision making and action. The combined experience of our seasoned leadership team spans research, clinical development, business development, and financing. Our individual track records pave the way for long-term success.
Value proposition of Serodus’ business model is to:
• utilize its expertise and proprietary know-how to optimize and develop its patent protected compounds from their present states when licensed or acquired and continue development through Phase IIb
• to out-license the drug candidate not later than after Phase II to pharmaceutical companies capable of performing the pharmaceutical and clinical development and ultimately, commercialize the drug
• continue to use its research, clinical experience, regulatory and market knowhow to identify new drug candidates of both small molecules and peptides covering significant unmet clinical needs and having commercial potential within the cardiovascular and metabolic therapeutic area.
Serodus is dedicated to the development of drug candidates to treat cardiovascular and metabolic diseases where today’s medical treatment is no longer efficacious enough. Serodus’ drug candidates are all developed in pharmaceutical areas where no current treatment is available. Consequently, the Serodus drug candidates will improve quality of life by reducing symptoms and risks of serious complications and reduce public health cost in:
• Therapy Resistant Isolated Systolic Hypertension (TRISH) (SER100) – by reducing the systolic blood pressure in patients with treatment-resistant isolated systolic blood pressure and in treatment with at least 3 other antihypertiva drugs and thereby reducing the risk of stroke, heart attack and renal failure.
The prevalence of Isolated Systolic Hypertention (ISH) is increasing with age and elevated systolic blood pressure is the dominating risk factor for stroke, heart failure, kidney disease and dementia. The evidence based recommended medicine for treatment of ISH is the same as for treatment of the combined diastolic and systolic hypertension, a thiazide and/or an ACE inhibitor and/or an angiotensin receptor blocker, and/or a calcium channel blocker and/or a beta-receptor blocker or combinations hereof. These drugs are all developed for reduction of the diastolic blood pressure or heart failure and demonstrated a secondary decrease in systolic blood pressure. When treated with as many as 3 different antihypertesives or more the condition is defined as therapy resistant isolated systolic hypertension if systolic blood pressure is still above 140 mmHG in non-diabetics and above 130 mmHg in diabetic patients . The therapeutic armamentarium has run out and new drugs with new mechanism of actions are clearly needed.
A Phase IIa study has been successfully been finalized and the planning for next step Phase IIb are planned.
• Acute Myocardial Infarction (AMI) (SER130) – by reducing the size of scar area after coronary occlusion and thereby reducing the severity of heart problems after a heart attack – arrhythmias and heart failure.
Acute myocardial infarction (AMI) remains a leading cause of morbidity and mortality worldwide. Myocardial infarction occurs when myocardial ischemia, caused by a diminished blood supply to an area of the heart, exceeds a critical threshold. Ischemia at this critical threshold level for an extended period results in irreversible myocardial cell damage or death. The incidence of AMI increases with age. In the future, as demographics shift and the mean age of the population increases, a larger percentage of patients presenting with AMI will be older than 65 years and the prevalence will increase. A patient experiencing an AMI is suffering from severe pain and maybe unstable cardiovascular function. The goals of therapy in acute AMI are to introduce pain relief, stabilized heart function and to restore normal coronary blood flow.
The preclinical safety and tolerability study has been finalized and the product candidate is ready to enter the Phase I/IIa study.
• Diabetic Nephropathy (DN) (SER150) – by reducing the diabetic inflammatory process in the kidney and thereby preserve kidney function and delay the need of dialysis.
Diabetic nephropathy (DN) is a major cause of increased morbidity and mortality due to development of chronic vascular inflammation. This is caused by hyperglycemia, especially the glucose spikes following meals that promote oxidative stress and subsequently drive inflammatory processes in the vascular bed. Proteinuria is a marker of this inflammatory process in the kidney and is an indicator of damaged renal function. The lower the kidney function the more protein is excreted to the urine. Thus, proteinuria is a predictor of morbidity and mortality. Loss of kidney function is a progressive condition and if not stopped, it ends with chronic dialysis and in some cases kidney transplantation.
A Phase IIa study was initiated in June 2015 with an expectancy to be finalized mid-2016.
• Type 2 Diabetes (T2D) (SER140) – to delay development of type 2 diabetes and thereby maintain normal regulation of blood glucose and metabolism and thereby prevent late diabetic complications such as renal disease, blindness, heart attack, stroke and wounds.
There is no cure for diabetes, and current therapy aims at reduce both the average blood glucose and the peak blood glucose after meals. The better the blood glucose is controlled by poly-pharmacological strategies the higher is the risk of cardiovascular and microvascular late diabetic complications reduced.. None of the current anti-diabetic therapies target underlying pathogenetic mechanisms (1). T2D constitutes 90% of the diabetes problem and occurs when pancreatic b-cell insulin secretion fails to compensate for insulin resistance due to obesity. T2D is associated with low-grade chronic systemic inflammation, reflected by discrete but significant increased levels of acute phase reactants, driven by cytokines produced by inflammatory cells in adipose tissue and liver. The endogenous cytokine IL-1 is a pro-inflammatory protein, which has been proven to be involved in the inflammatory process around the insulin producing pancreatic cells (the b-cells).
The drug candidate has finalized a pharmacological test in clinical relevant animal model and has proven anti-diabetic potential. The candidate is ready to enter into preclinical studies.
• Pulmonary Hypertension (PH) (SER100) – by reducing the blood pressure in patients with elevated blood pressure in the pulmonary arteries and thereby shorten stay in hospital and reduce number of hospitalization.
Pulmonary arterial hypertension (PH) is characterized by an abnormal elevation of the pulmonary artery pressure, the arteries that carry blood from the heart to the lungs. The arteries become narrowed and lead to a progressive increase of pulmonary vascular resistance, making it difficult for blood to flow through the vessels. As a result, right ventricle increase the systolic pressure and the blood pressure in pulmonary arteries rises far above normal levels. Despite improvements in the diagnosis and management of PH over the past 2 decades with the introduction of targeted medical therapies leading to improved survival, the disease continues to have a poor long-term prognosis.
The product candidate is ready to enter Phase IIa safety study in patients with pulmonary hypertension caused by pulmonary embolus or pulmonary thrombosis. An orphan drug designation will be applied for.
The 4 drug candidates and the 5 indications are covered by extensive intellectual properties (patents and pending patent applications) held by either the Serodus (SER100, SER140 and SER200), Evolva (SER150 and related compounds) or University of Copenhagen (SER130). Serodus has all development and commercial rights to all the drug candidates.
For more information on Serodus and our product pipeline please see www.serodus.com.